Docetaxel Lipid Microsphere (DT-LM) is a novel proprietary delivery system of docetaxel developed by Shenyang Pharmaceutical University. In this Phase I study, the DT-LM was evaluated for the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) in patients with advance solid tumors. It was also evaluated for pharmacokinetic and anti-tumor effects of DT-LM compared to commerical docetaxel.
Docetaxel (currently marketed as Taxotere®), given by intravenous or intraperitoneal injection, has contributed significantly to the treatment of a variety of malignancies, such as ovarian, breast, gastric, and non-small-cell lung cancer (NSCLC), as well as head and neck cancer and some other cancers. In the preclinical, DT-LM showed reduced toxicity (especially myelosuppression)and comparable therapeutic efficacy. In clinic, it is believed that DT-LM will offer fewer side effects to the patient at similar doses, and possibly greater effectiveness when used at higher doses. DT-LM could not only avoid the serious hypersensitivity reactions caused by Tween 80, but also be stable, safe and convenient for clinical administration. This study is designed to determine the following: * The maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of DT-LM. * The pharmacokinetics of docetaxel following intravenous administration of DT-LM. * Any anti-tumor effects of DT-LM. Controlled trial is also carrying out to reveal the differences in safety, pharmacokinetics and pharmacodynamics between DT-LM and Taxotere.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Cancer Institute & Hospital, Chinese Academy of Medical Sciences
Beijing, China
RECRUITINGThe safety and tolerability
This Phase I, open-label, control,dose-escalation study was designed to determine the maximum tolerated dose (MTD) of DT-LM in patients with advanced cancer. DT-LM was administered by intravenous infusion, over 1 hour, once every 21 days until occurrence of disease progression or toxicity requiring early treatment discontinuation. Dose escalation was not done until the safety and tolerability at a given dose level has been confirmed.
Time frame: one year
Assessment of pharmacokinetics of DT-LM and Taxotere: AUC and Cmax
The patients were evaluated for pharmacokinetic profile of DT-LM and Taxotere upto 48 hours post treatment after cycle 1 and cycle 2,respectively.
Time frame: one year
Objective tumour response according to RECIST
The anti-tumor effects were evaluated after every two cycles of treatment.
Time frame: one year
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